Multi-channel neuromodulation system having frequency modulation stimulation

ABSTRACT

A neuromodulation system comprises a plurality of electrical terminals configured for being respectively coupled to electrodes, modulation output circuitry configured for respectively outputting a plurality of individual electrical pulse trains in a plurality of timing channels to the electrical terminals, wherein each of the timing channels prevents the respective pulse train from having a specific characteristic, and control circuitry configured for controlling the modulation output circuitry in a manner that outputs the pulse trains to a common set of the electrical terminals, thereby creating a combined electrical pulse train at the common set of electrical terminals that has the specific characteristic. A method of providing therapy to a patient comprises delivering a plurality of electrical pulse trains respectively in a plurality of timing channels to a common set of electrodes implanted within the patient, thereby creating a combined electrical pulse train at the common set of electrical terminals.

RELATED APPLICATION DATA

The present application is a continuation of U.S. application Ser. No.14/186,885, filed Feb. 21, 2014, which claims the benefit under 35U.S.C. §119 to U.S. provisional patent application Ser. No. 61/768,286,filed Feb. 22, 2013. The foregoing applications are hereby incorporatedby reference into the present application in their entirety.

FIELD OF THE INVENTION

The present invention relates to neuromodulation systems, and moreparticularly, to multi-channel neuromodulation systems.

BACKGROUND OF THE INVENTION

Implantable neuromodulation systems have proven therapeutic in a widevariety of diseases and disorders. Pacemakers and Implantable CardiacDefibrillators (ICDs) have proven highly effective in the treatment of anumber of cardiac conditions (e.g., arrhythmias). Spinal CordStimulation (SCS) systems have long been accepted as a therapeuticmodality for the treatment of chronic pain syndromes, and theapplication of tissue stimulation has begun to expand to additionalapplications such as angina pectoralis and incontinence. Deep BrainStimulation (DBS) has also been applied therapeutically for well over adecade for the treatment of refractory chronic pain syndromes, and DBShas also recently been applied in additional areas such as movementdisorders and epilepsy. Further, in recent investigations, PeripheralNerve Stimulation (PNS) systems have demonstrated efficacy in thetreatment of chronic pain syndromes and incontinence, and a number ofadditional applications are currently under investigation. Furthermore,Functional Electrical Stimulation (FES) systems, such as the Freehandsystem by NeuroControl (Cleveland, Ohio), have been applied to restoresome functionality to paralyzed extremities in spinal cord injurypatients.

These implantable neuromodulation systems typically include one or moreelectrode carrying modulation leads, which are implanted at the desiredstimulation site, and a neuromodulator (e.g., an implantable pulsegenerator (IPG)) implanted remotely from the stimulation site, butcoupled either directly to the modulation lead(s) or indirectly to themodulation lead(s) via a lead extension. The neuromodulation system mayfurther comprise an external control device to remotely instruct theneuromodulator to generate electrical modulation pulses in accordancewith selected modulation parameters.

Electrical modulation energy may be delivered from the neuromodulator tothe electrodes in the form of a pulsed electrical waveform. Thus,modulation energy may be controllably delivered to the electrodes tostimulate neural tissue. The combination of electrodes used to deliverelectrical pulses to the targeted tissue constitutes an electrodecombination, with the electrodes capable of being selectively programmedto act as anodes (positive), cathodes (negative), or left off (zero). Inother words, an electrode combination represents the polarity beingpositive, negative, or zero. Other parameters that may be controlled orvaried include the amplitude, duration, and rate of the electricalpulses provided through the electrode array. Each electrode combination,along with the electrical pulse parameters, can be referred to as a“modulation parameter set.”

With some neuromodulation systems, and in particular, those withindependently controlled current or voltage sources, the distribution ofthe current to the electrodes (including the case of the neuromodulator,which may act as an electrode) may be varied such that the current issupplied via numerous different electrode configurations. In differentconfigurations, the electrodes may provide current or voltage indifferent relative percentages of positive and negative current orvoltage to create different electrical current distributions (i.e.,fractionalized electrode configurations).

As briefly discussed above, an external control device can be used toinstruct the neuromodulator to generate electrical modulation pulses inaccordance with the selected modulation parameters. Typically, themodulation parameters programmed into the neuromodulator can be adjustedby manipulating controls on the external control device to modify theelectrical stimulation provided by the neuromodulator system to thepatient. However, the number of electrodes available combined with theability to generate a variety of complex modulation pulses, presents avast selection of modulation parameter sets to the clinician or patient.

To facilitate such selection, the clinician generally programs theneuromodulator through a computerized programming system. Thisprogramming system can be a self-contained hardware/software system, orcan be defined predominantly by software running on a standard personalcomputer (PC). The PC or custom hardware may actively control thecharacteristics of the electrical stimulation generated by theneuromodulator to allow the optimum modulation parameters to bedetermined based on patient feedback or other means and to subsequentlyprogram the neuromodulator with the optimum modulation parameter set orsets, which will typically be those that stimulate all of the targettissue in order to provide the therapeutic benefit, yet minimizes thevolume of non-target tissue that is stimulated. The computerizedprogramming system may be operated by a clinician attending the patientin several scenarios.

Often, multiple timing channels are used when applying electricalmodulation energy to target different tissue regions in a patient. Forexample, in the context of SCS, the patient may simultaneouslyexperience pain in different regions (such as the lower back, left arm,and right leg) that would require the electrical stimulation ofdifferent spinal cord tissue regions. In the context of DBS, a multitudeof brain structures may need to be electrically stimulated in order tosimultaneously treat ailments associated with these brain structures.Each timing channel identifies the combination of electrodes used todeliver electrical pulses to the targeted tissue, as well as thecharacteristics of the current (pulse amplitude, pulse duration, pulserate, etc.) flowing through the electrodes.

As is conventional, the ability of each timing channel to generatemodulation energy it typically limited. For example, the maximum pulseamplitude and/or pulse rate that each timing channel can provide may belimited. Furthermore, the nature of the pulse rate for each timingchannel may be limited in that it must be uniform. Although these timingchannels can be used in combination for providing modulation energy todifferent tissue regions of a patient, most often, there arerestrictions on operating the timing channels together (e.g., themaximum rate of each channel may be limited when multiple timingchannels are programmed to operate simultaneously). Furthermore, thetiming channels are often operated independent of each other to createseparate modulation effects that the different tissue regions. Whileneuromodulation systems can be designed with hardware capable ofaddressing these concerns, redesigning the hardware on presentlyexisting neuromodulation designs to accommodate these pulse trains maybe a monumental task. Furthermore, neuromodulation systems that arecurrently used in the field may not be easily updated to eliminate theselimitations from the timing channels.

There, thus, remains a need to provide an improved technique forincreasing the modulation flexibility of presently existingmulti-channel neuromodulation systems.

SUMMARY OF THE INVENTION

In accordance with one aspect of the present inventions, aneuromodulation system comprises a plurality of electrical terminalsconfigured for being respectively coupled to a plurality of electrodes,and modulation output circuitry configured for respectively outputting aplurality of individual electrical pulse trains in a plurality of timingchannels to the plurality of electrical terminals. Each of the timingchannels prevents the respective pulse train from having a specificcharacteristic. The neuromodulation system further comprises controlcircuitry configured for controlling the modulation output circuitry ina manner that outputs the plurality of pulse trains to a common set ofthe electrical terminals (which may be a single electrical terminal ormultiple electrical terminals), thereby creating a combined electricalpulse train at the common set of electrical terminals that has thespecific characteristic.

In one embodiment, the specific characteristic is a pulse amplitude thatexceeds a maximum value, in which case, the combined electrical pulsetrain has the pulse amplitude that exceeds the maximum value. In anotherembodiment, the specific characteristic is a pulse rate that exceeds amaximum value, in which case, the combined electrical pulse train hasthe pulse rate that exceeds the maximum value. In still anotherembodiment, the specific characteristic is a varying pulse rate, inwhich case, the combined electrical pulse train has a varying pulserate. The pulses of the plurality of pulse trains may be interleaved tocreate the combined electrical pulse train with the varying pulse rate,or may be sequentially burst to create the combined electrical pulsetrain with a plurality of burst patterns having different pulse rates.

In an optional embodiment, the neuromodulation system further comprisesa user interface configured for receiving an input from a user definingthe specific characteristic. In another optional embodiment, theneuromodulation system may further comprise a memory configured forstoring a plurality of stimulation programs, in which case, the controlcircuitry may be configured for programming the plurality of timingchannels for each of the stimulation programs. The neurostimulation mayfurther comprise casing containing the plurality of electricalterminals, the modulation output circuitry, and the control circuitry.

In accordance with another aspect of the present inventions, a method ofproviding therapy to a patient is provided. The method further comprisesdelivering a plurality of electrical pulse trains respectively in aplurality of timing channels to a common set of electrodes (which mayinclude a single electrode or multiple electrodes) implanted within thepatient, thereby creating a combined electrical pulse train at thecommon set of electrical terminals and providing the therapy to thepatient. In one method, the modulation pulses of the plurality pulsetrains overlap each other, such that the combined pulse train has apulse amplitude equal to the sum of the pulse amplitudes of theplurality of pulse trains. In another method, the modulation pulses ofthe plurality pulse trains are interleaved, such that the combined pulsetrain has a pulse rate equal to the sum of the pulse rates of theplurality of pulse trains. In still another method, the plurality ofpulse trains are sequentially burst to create the combined electricalpulse train with a plurality of burst patterns having different pulserates. An optional method further comprises receiving input from a userdefining a characteristic of the combined pulse train.

Other and further aspects and features of the invention will be evidentfrom reading the following detailed description of the preferredembodiments, which are intended to illustrate, not limit, the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of preferred embodimentsof the present invention, in which similar elements are referred to bycommon reference numerals. In order to better appreciate how theabove-recited and other advantages and objects of the present inventionsare obtained, a more particular description of the present inventionsbriefly described above will be rendered by reference to specificembodiments thereof, which are illustrated in the accompanying drawings.Understanding that these drawings depict only typical embodiments of theinvention and are not therefore to be considered limiting of its scope,the invention will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 is a plan view of an embodiment of a spinal cord modulation (SCM)system arranged in accordance with the present inventions;

FIG. 2 is a plan view of the SCM system of FIG. 1 in use with a patient;

FIG. 3 is a profile view of an implantable pulse generator (IPG) andpercutaneous leads used in the SCM system of FIG. 1;

FIG. 4 is a plot of monophasic cathodic electrical modulation energy;

FIG. 5 a is a plot of biphasic electrical modulation energy having acathodic modulation pulse and an active charge recovery pulse;

FIG. 5 b is a plot of biphasic electrical modulation energy having acathodic modulation pulse and a passive charge recovery pulse;

FIG. 6 is a timing diagram illustrating a first technique for combiningpulsed electrical waveforms delivered within multiple timing channels ofthe IPG of FIG. 3;

FIG. 7 is a timing diagram illustrating a second technique for combiningpulsed electrical waveforms delivered within multiple timing channels ofthe IPG of FIG. 3;

FIG. 8 is a timing diagram illustrating a third technique for combiningpulsed electrical waveforms delivered within multiple timing channels ofthe IPG of FIG. 3;

FIG. 9 is a timing diagram illustrating a fourth technique for combiningpulsed electrical waveforms delivered within multiple timing channels ofthe IPG of FIG. 3; and

FIG. 10 is a block diagram of the internal components of the IPG of FIG.3.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The description that follows relates to a spinal cord modulation (SCM)system. However, it is to be understood that while the invention lendsitself well to applications in spinal cord modulation, the invention, inits broadest aspects, may not be so limited. Rather, the invention maybe used with any type of implantable electrical circuitry used tostimulate tissue. For example, the present invention may be used as partof a pacemaker, a defibrillator, a cochlear stimulator, a retinalstimulator, a stimulator configured to produce coordinated limbmovement, a cortical stimulator, a deep brain stimulator, peripheralnerve stimulator, microstimulator, or in any other neurostimulatorconfigured to treat urinary incontinence, sleep apnea, shouldersublaxation, headache, etc.

Turning first to FIG. 1, an exemplary SCM neuromodulation system 10generally includes one or more (in this case, two) implantablemodulation leads 12, an implantable pulse generator (IPG) 14, anexternal remote controller RC 16, a clinician's programmer (CP) 18, anExternal Trial Modulator (ETM) 20, and an external charger 22.

The IPG 14 is physically connected via one or more percutaneous leadextensions 24 to the modulation leads 12, which carry a plurality ofelectrodes 26 arranged in an array. In the illustrated embodiment, themodulation leads 12 are percutaneous leads, and to this end, theelectrodes 26 may be arranged in-line along the modulation leads 12. Inalternative embodiments, the electrodes 26 may be arranged in atwo-dimensional pattern on a single paddle lead. As will be described infurther detail below, the IPG 14 includes pulse generation circuitrythat delivers electrical modulation energy in the form of a pulsedelectrical waveform (i.e., a temporal series of electrical pulses) tothe electrode array 26 in accordance with a set of modulationparameters.

The ETM 20 may also be physically connected via the percutaneous leadextensions 28 and external cable 30 to the modulation leads 12. The ETM20, which has similar pulse generation circuitry as the IPG 14, alsodelivers electrical modulation energy in the form of a pulse electricalwaveform to the electrode array 26 accordance with a set of modulationparameters. The major difference between the ETM 20 and the IPG 14 isthat the ETM 20 is a non-implantable device that is used on a trialbasis after the modulation leads 12 have been implanted and prior toimplantation of the IPG 14, to test the responsiveness of thestimulation that is to be provided. Thus, any functions described hereinwith respect to the IPG 14 can likewise be performed with respect to theETM 20.

The RC 16 may be used to telemetrically control the ETM 20 via abi-directional RF communications link 32. Once the IPG 14 and modulationleads 12 are implanted, the RC 16 may be used to telemetrically controlthe IPG 14 via a bi-directional RF communications link 34. Such controlallows the IPG 14 to be turned on or off and to be programmed withdifferent modulation parameter sets. The IPG 14 may also be operated tomodify the programmed modulation parameters to actively control thecharacteristics of the electrical modulation energy output by the IPG14. As will be described in further detail below, the CP 18 providesclinician detailed modulation parameters for programming the IPG 14 andETM 20 in the operating room and in follow-up sessions.

The CP 18 may perform this function by indirectly communicating with theIPG 14 or ETM 20, through the RC 16, via an IR communications link 36.Alternatively, the CP 18 may directly communicate with the IPG 14 or ETM20 via an RF communications link (not shown). The clinician detailedmodulation parameters provided by the CP 18 are also used to program theRC 16, so that the modulation parameters can be subsequently modified byoperation of the RC 16 in a stand-alone mode (i.e., without theassistance of the CP 18).

The external charger 22 is a portable device used to transcutaneouslycharge the IPG 14 via an inductive link 38. For purposes of brevity, thedetails of the external charger 22 will not be described herein. Oncethe IPG 14 has been programmed, and its power source has been charged bythe external charger 22 or otherwise replenished, the IPG 14 mayfunction as programmed without the RC 16 or CP 18 being present.

For purposes of brevity, the details of the RC 16, CP 18, ETM 20, andexternal charger 22 will not be described herein. Details of exemplaryembodiments of these devices are disclosed in U.S. Pat. No. 6,895,280,which is expressly incorporated herein by reference.

As shown in FIG. 2, the modulation leads (or lead) 12 are implantedwithin the spinal column 42 of a patient 40. The preferred placement ofthe modulation leads 12 is adjacent, i.e., resting near, or upon thedura, adjacent to the spinal cord area to be stimulated. Theneuromodulation leads 12 will be located in a vertebral position thatdepends upon the location and distribution of the chronic pain. Forexample, if the chronic pain is in the lower back or legs, themodulation leads 12 may be located in the mid- to low-thoracic region(e.g., at the T9-12 vertebral levels). Due to the lack of space near thelocation where the modulation leads 12 exit the spinal column 42, theIPG 14 is generally implanted in a surgically-made pocket either in theabdomen or above the buttocks. The IPG 14 may, of course, also beimplanted in other locations of the patient's body. The lead extensions24 facilitate locating the IPG 14 away from the exit point of theelectrode leads 12. As there shown, the CP 18 communicates with the IPG14 via the RC 16.

Referring now to FIG. 3, the features of the modulation leads 12 and theIPG 14 will be briefly described. One of the modulation leads 12(1) haseight electrodes 26 (labeled E1-E8), and the other modulation lead 12(2)has eight electrodes 26 (labeled E9-E16). The actual number and shape ofleads and electrodes will, of course, vary according to the intendedapplication. The IPG 14 comprises an outer case 44 for housing theelectronic and other components (described in further detail below), anda connector 46 to which the proximal ends of the modulation leads 12mates in a manner that electrically couples the electrodes 26 to theelectronics within the outer case 40. The outer case 44 is composed ofan electrically conductive, biocompatible material, such as titanium,and forms a hermetically sealed compartment wherein the internalelectronics are protected from the body tissue and fluids. In somecases, the outer case 40 may serve as an electrode.

As will be described in further detail below, the IPG 14 includes abattery and pulse generation circuitry that delivers the electricalmodulation energy in the form of one or more electrical pulse trains tothe electrode array 26 in accordance with a set of modulation parametersprogrammed into the IPG 14. Such modulation parameters may compriseelectrode combinations, which define the electrodes that are activatedas anodes (positive), cathodes (negative), and turned off (zero),percentage of modulation energy assigned to each electrode(fractionalized electrode configurations), and electrical pulseparameters, which define the pulse amplitude (measured in milliamps orvolts depending on whether the IPG 14 supplies constant current orconstant voltage to the electrode array 26), pulse duration (measured inmicroseconds), pulse rate (measured in pulses per second), interphase(measured in microseconds between two phases of a biphasic pulse), andburst rate (measured as the modulation on duration X and modulation offduration Y).

Electrical modulation will occur between two (or more) activatedelectrodes, one of which may be the IPG case 44. Modulation energy maybe transmitted to the tissue in a monopolar or multipolar (e.g.,bipolar, tripolar, etc.) fashion. Monopolar modulation occurs when aselected one of the lead electrodes 26 is activated along with the caseof the IPG 14, so that modulation energy is transmitted between theselected electrode 26 and case. Bipolar modulation occurs when two ofthe lead electrodes 26 are activated as anode and cathode, so thatmodulation energy is transmitted between the selected electrodes 26. Forexample, electrode E3 on the first lead 12(1) may be activated as ananode at the same time that electrode E11 on the second lead 12(1) isactivated as a cathode. Tripolar modulation occurs when three of thelead electrodes 26 are activated, two as anodes and the remaining one asa cathode, or two as cathodes and the remaining one as an anode. Forexample, electrodes E4 and E5 on the first lead 12 may be activated asanodes at the same time that electrode E12 on the second lead 12 isactivated as a cathode

The modulation energy may be delivered between a specified group ofelectrodes as monophasic electrical energy or multiphasic electricalenergy. As illustrated in FIG. 4, monophasic electrical energy takes theform of an electrical pulse train that includes either all negativepulses (cathodic), or alternatively all positive pulses (anodic).

Multiphasic electrical energy includes a series of pulses that alternatebetween positive and negative. For example, as illustrated in FIGS. 5 aand 5 b, multiphasic electrical energy may include a series of biphasicpulses, with each biphasic pulse including a cathodic (negative)modulation pulse (during a first phase) and an anodic (positive) chargerecovery pulse (during a second phase) that is generated after themodulation pulse to prevent direct current charge transfer through thetissue, thereby avoiding electrode degradation and cell trauma. That is,charge is conveyed through the electrode-tissue interface via current atan electrode during a modulation period (the length of the modulationpulse), and then pulled back off the electrode-tissue interface via anoppositely polarized current at the same electrode during a rechargeperiod (the length of the charge recovery pulse).

The second phase may have an active charge recovery pulse (FIG. 5 a),wherein electrical current is actively conveyed through the electrodevia current or voltage sources, and a passive charge recovery pulse, orthe second phase may have a passive charge recovery pulse (FIG. 5 b),wherein electrical current is passively conveyed through the electrodevia redistribution of the charge flowing from coupling capacitancespresent in the circuit. Using active recharge, as opposed to passiverecharge, allows faster recharge, while avoiding the charge imbalancethat could otherwise occur. Another electrical pulse parameter in theform of an interphase can define the time period between the pulses ofthe biphasic pulse (measured in microseconds).

Significant to the present inventions, the SCM system 10 is capable ofconcurrently delivering a plurality of individual electrical pulsetrains through a respective plurality of timing channels to a common setof electrodes, thereby creating a combined electrical pulse train at thecommon electrode set. For the purposes of this specification, electricalpulse trains are concurrently conveyed if any of their pulses overlap orare interleaved relative to each other. In a preferred method, theindividual pulse trains are respectively conveyed from the plurality ofelectrodes to the common electrode (or electrodes) via tissue of thepatient. Preferably, the tissue adjacent the common electrode (orelectrodes) is therapeutically modulated (e.g., stimulated) by thecombined electrical pulse train to provide the therapy. Advantageously,using multiple timing channels to combine electrical pulse trains into asingle electrical pulse train at a common set of electrodes enables theSCM system 10 to create an electrical pulse train that may not otherwisebe able to be created using a single timing channel due to hardwarelimitations in the SCM system 10.

In particular, the hardware of the SCM system 10 prevents the individualpulse trains conveyed in the respective timing channels from havingspecific characteristics, which may occur in the combined electricalpulse train. Thus, although the timing channels may prevent the deliveryof individual pulse trains having certain characteristics from beingdelivered to a common set of electrodes, a combined pulse train havingsuch characteristics may be delivered to the common set of electrodes.

For example, the specific characteristic may be a pulse amplitude thatexceeds a maximum value (i.e., single channel modulation is limited inthat the pulse amplitude of each of the individual pulse trains cannotexceed a maximum value), in which case, the combined electrical pulsetrain may have the pulse amplitude that exceeds the maximum value. Thecombined electrical pulse train may be created by overlapping themodulation pulses of the individual pulse trains with each other, suchthat the combined pulse train has a pulse amplitude equal to the sum ofthe pulse amplitudes of the individual pulse trains.

As shown in FIG. 6, two individual electrical pulse trains 60 a and 60 bare respectively delivered in two timing channels T1 and T2 to a commonelectrode set (e.g., electrode E1) to create a single combinedelectrical pulse train 60 at the common electrode set. In theillustrated embodiment, the single combined electrical pulse train 60includes a series of biphasic pulses 62, each of which is created bysimultaneously delivering biphasic modulation pulses 62 a and 62 b ofthe respective individual electrical pulse trains 60 a and 60 b to thecommon electrode set. As shown in FIG. 6, the pulse amplitude of thecombined pulse train 60 is greater than the pulse amplitude of either ofthe individual pulse trains 60 a and 60 b, and in particular, equal tothe sum of the pulse amplitudes of the pulse trains 60 a and 60 b. Ineffect, the amplitude of the pulse amplitude of the electrical pulsetrain delivered to the common set of electrodes is boosted.

As another example, the specific characteristic may be a pulse rate thatexceeds a maximum value (i.e., single channel modulation is limited inthat the pulse rate of each of the individual pulse trains cannot exceeda maximum value), in which case, the combined electrical pulse train mayhave the pulse rate that exceeds the maximum value. The combinedelectrical pulse train may be created by interleaving the modulationpulses of the individual pulse trains with each other, such that thecombined pulse train has a pulse rate equal to the sum of the pulserates of the individual pulse trains.

As shown in FIG. 7, two individual electrical pulse trains 60 a and 60 bare respectively delivered in two timing channels T1 and T2 to a commonelectrode set (e.g., electrode E1) to create a single combinedelectrical pulse train 60 at the common electrode set. In theillustrated embodiment, the single combined electrical pulse train 60includes a series of biphasic pulses 62, each of which is created bydelivering biphasic modulation pulses 62 a and 62 b of the respectiveindividual electrical pulse trains 60 a and 60 b to the common electrodeset in an interleaving manner. As shown in FIG. 7, the pulse rate of thecombined pulse train 60 is greater than the pulse rate of either of theindividual pulse trains 60 a and 60 b, and in particular, equal to thesum of the pulse rates of the pulse trains 60 a and 60 b. In theillustrated embodiment, the pulse rates of the individual pulse trains60 a and 60 b are equal to each other, and thus, the pulse rate of thecombined pulse train 60 is uniform and twice the pulse rate of each ofthe pulse trains 60 a and 60 b.

As still another example, the specific characteristic may be a varyingpulse rate (i.e., single channel modulation is limited in that the pulserate of each of the individual pulse trains must be uniform), in whichcase, the combined electrical pulse train may have a varying pulse rate.The combined electrical pulse train may be created by interleaving themodulation pulses of the individual pulse trains with each other, suchthat the combined pulse train has varying pulse rate.

As shown in FIG. 8, four individual electrical pulse trains 60 a-60 dare respectively delivered in four timing channels T1-T4 to a commonelectrode set (e.g., electrode E1) to create a single combinedelectrical pulse train 60 at the common electrode set. In theillustrated embodiment, the single combined electrical pulse train 60includes a series of monophasic pulses 62, each of which is created bydelivering monophasic modulation pulses 62 a-62 d of the respectiveindividual electrical pulse trains 60 a-60 d to the common electrode setin an interleaving manner. As shown in FIG. 8, the pulse rate of thecombined pulse train 60 varies between a relatively high level and arelatively low level.

As yet another example, the specific characteristic may be a sequence ofbursting patterns having differing pulse rates (i.e., single channelmodulation is limited in that each of the individual pulse trains canonly be burst on and off with a fixed pulse rate), in which case, thecombined electrical pulse train may have a series of bursting patternswith varying pulse rates. In this case, rather than concurrentlyconveying the electrical pulse trains, as shown in FIGS. 6-8, theelectrical pulse trains may be sequentially burst on and off to create acombined electrical pulse train having a plurality of burst patternswith different pulse rates.

As shown in FIG. 9, four individual electrical pulse trains 60 a-60 dare respectively delivered in four timing channels T1-T4 to a commonelectrode set (e.g., electrode E1) to create a single combinedelectrical pulse train 60 at the common electrode set. In theillustrated embodiment, the single combined electrical pulse train 60includes a series of pulses 62, each of which is created by sequentiallydelivering bursts of modulation pulses 62 a-62 d of the respectiveindividual electrical pulse trains 60 a-60 d to the common electrodeset. As shown in FIG. 9, the combined pulse train 60 includes a firstbursting pattern 62 a obtained from the first pulse train 60 a, then asecond bursting pattern 62 b obtained from the second pulse train 60 b,then a third bursting pattern 62 c obtained from the third pulse train60 c, and finally a fourth bursting pattern 62 d obtained from thefourth pulse train 60 d.

Turning next to FIG. 10, the main internal components of the IPG 14 willnow be described. The IPG 14 includes modulation output circuitry 100configured for generating electrical modulation energy in accordancewith a defined pulsed waveform having a specified pulse amplitude, pulserate, pulse width, pulse shape, and burst rate under control of controllogic 102 over data bus 104. Control of the pulse rate and pulse widthof the electrical waveform is facilitated by timer logic circuitry 106,which may have a suitable resolution, e.g., 10 μs. The modulation energygenerated by the modulation output circuitry 100 is output viacapacitors C1-C16 to electrical terminals 108 corresponding to theelectrodes 26. The analog output circuitry 100 may either compriseindependently controlled current sources for providing modulation pulsesof a specified and known amperage to or from the electrodes 26, orindependently controlled voltage sources for providing modulation pulsesof a specified and known voltage at the electrodes 26.

Any of the N electrodes may be assigned to up to k possible groups ortiming “channels.” In one embodiment, k may equal four. The timingchannel identifies which electrodes are selected to synchronously sourceor sink current to create an electric field in the tissue to bestimulated. Amplitudes and polarities of electrodes on a channel mayvary, e.g., as controlled by the RC 16. External programming software inthe CP 18 is typically used to set modulation parameters includingelectrode polarity, amplitude, pulse rate, pulse duration, interphase,bursting rate, and bursting duty cycle for the electrodes of a givenchannel, among other possible programmable features.

The N programmable electrodes can be programmed to have a positive(sourcing current), negative (sinking current), or off (no current)polarity in any of the k channels. Moreover, each of the N electrodescan operate in a multipolar (e.g., bipolar) mode, e.g., where two ormore electrode contacts are grouped to source/sink current at the sametime. Alternatively, each of the N electrodes can operate in a monopolarmode where, e.g., the electrode contacts associated with a channel areconfigured as cathodes (negative), and the case electrode (i.e., the IPGcase) is configured as an anode (positive).

Further, the amplitude of the current pulse being sourced or sunk to orfrom a given electrode may be programmed to one of several discretecurrent levels, e.g., between □0 to □10 mA in steps of 0.1 mA. Also, thepulse duration of the current pulses is preferably adjustable inconvenient increments, e.g., from 0 to 1 milliseconds (ms) in incrementsof 10 microseconds (μs). Similarly, the pulse rate is preferablyadjustable within acceptable limits, e.g., from 0 to 1000 pulses persecond (pps). Other programmable features can include slow start/endramping, burst modulation cycling (on for X time, off for Y time),interphase, and open or closed loop sensing modes.

The operation of this analog output circuitry 100, including alternativeembodiments of suitable output circuitry for performing the samefunction of generating modulation pulses of a prescribed amplitude andduration, is described more fully in U.S. Pat. Nos. 6,516,227 and6,993,384, which are expressly incorporated herein by reference.

The IPG 14 further comprises monitoring circuitry 110 for monitoring thestatus of various nodes or other points 112 throughout the IPG 14, e.g.,power supply voltages, temperature, battery voltage, and the like. TheIPG 14 further comprises processing circuitry in the form of amicrocontroller (μC) 114 that controls the control logic over data bus116, and obtains status data from the monitoring circuitry 110 via databus 118. The IPG 14 additionally controls the timer logic 108. The IPG14 further comprises memory 120 and oscillator and clock circuitry 122coupled to the microcontroller 114. The microcontroller 114, incombination with the memory 120 and oscillator and clock circuitry 122,thus comprise a microprocessor system that carries out a programfunction in accordance with a suitable program stored in the memory 118.Alternatively, for some applications, the function provided by themicroprocessor system may be carried out by a suitable state machine.

Thus, the microcontroller 114 generates the necessary control and statussignals, which allow the microcontroller 114 to control the operation ofthe IPG 14 in accordance with a selected operating program andmodulation parameters stored in the memory 120. In controlling theoperation of the IPG 14, the microcontroller 114 is able to individuallygenerate an electrical pulse train at the electrodes 26 using themodulation output circuitry 100, in combination with the control logic102 and timer logic 106, thereby allowing each electrode 26 to be pairedor grouped with other electrodes 26, including the monopolar caseelectrode. In accordance with modulation parameters stored within thememory 118, the microcontroller 114 may control the polarity, amplitude,rate, pulse duration and timing channel through which the modulationpulses are provided.

Thus, it can be appreciated that, under control of the microcontroller114, the modulation output circuitry 100 is configured for outputting ak number of individual electrical pulse trains respectively in a knumber of timing channels to the electrical terminals 106, with eachelectrical pulse train including pulses as shown in FIGS. 4, 5 a and 5b. In the IPG 14, up to four stimulation programs may be stored in thememory 120, with each stimulation program having four timing channels.Thus, each modulation program defines four sets of modulation parametersfor four respective timing channels. Of course, the IPG 14 may have lessor more than four modulation programs, and less or more than four timingchannels for each modulation program. Significantly, the microcontroller114 may control the modulation output circuitry 100 in a manner thatdelivers multiple electrical pulse trains to a common set of theelectrical terminals 108 (and thus, a common set of electrodes 26) tocreate a single electrical pulse train at the common set of electricalterminals 108; for example, in the manner described in the techniquesillustrated in FIGS. 6-9. Because the functions of the microcontroller114 can be implemented in software, these techniques can be more easilyimplemented within the IPG 14 without modifying pre-existing hardwaredesigns.

The IPG 14 further comprises an alternating current (AC) receiving coil124 for receiving programming data (e.g., the operating program and/ormodulation parameters) from the RC 16 (shown in FIG. 2) in anappropriate modulated carrier signal, and charging and forward telemetrycircuitry 126 for demodulating the carrier signal it receives throughthe AC receiving coil 124 to recover the programming data, whichprogramming data is then stored within the memory 120, or within othermemory elements (not shown) distributed throughout the IPG 14.

The IPG 14 further comprises back telemetry circuitry 128 and analternating current (AC) transmission coil 130 for sending informationaldata sensed through the monitoring circuitry 110 to the RC 16. The backtelemetry features of the IPG 14 also allow its status to be checked.For example, when the RC 16 initiates a programming session with the IPG14, the capacity of the battery is telemetered, so that the externalprogrammer can calculate the estimated time to recharge. Any changesmade to the current stimulus parameters are confirmed through backtelemetry, thereby assuring that such changes have been correctlyreceived and implemented within the implant system. Moreover, uponinterrogation by the RC 16, all programmable settings stored within theIPG 14 may be uploaded to the RC 16. Significantly, the back telemetryfeatures allow raw or processed electrical parameter data (or otherparameter data) previously stored in the memory 120 to be downloadedfrom the IPG 14 to the RC 16, which information can be used to track thephysical activity of the patient.

The IPG 14 further comprises a rechargeable power source 132 and powercircuits 134 for providing the operating power to the IPG 14. Therechargeable power source 132 may, e.g., comprise a lithium-ion orlithium-ion polymer battery. The rechargeable battery 132 provides anunregulated voltage to the power circuits 134. The power circuits 134,in turn, generate the various voltages 136, some of which are regulatedand some of which are not, as needed by the various circuits locatedwithin the IPG 14. The rechargeable power source 132 is recharged usingrectified AC power (or DC power converted from AC power through othermeans, e.g., efficient AC-to-DC converter circuits, also known as“inverter circuits”) received by the AC receiving coil 134. To rechargethe power source 132, an external charger (not shown), which generatesthe AC magnetic field, is placed against, or otherwise adjacent, to thepatient's skin over the implanted IPG 14. The AC magnetic field emittedby the external charger induces AC currents in the AC receiving coil134. The charging and forward telemetry circuitry 136 rectifies the ACcurrent to produce DC current, which is used to charge the power source132. While the AC receiving coil 134 is described as being used for bothwirelessly receiving communications (e.g., programming and control data)and charging energy from the external device, it should be appreciatedthat the AC receiving coil 134 can be arranged as a dedicated chargingcoil, while another coil, such as coil 130, can be used forbi-directional telemetry.

It should be noted that the diagram of FIG. 10 is functional only, andis not intended to be limiting. Those of skill in the art, given thedescriptions presented herein, should be able to readily fashionnumerous types of IPG circuits, or equivalent circuits, that carry outthe functions indicated and described, which functions include not onlyproducing a stimulus current or voltage on selected groups ofelectrodes, but also the ability to measure electrical parameter data atan activated or non-activated electrode.

Additional details concerning the above-described and other IPGs may befound in U.S. Pat. No. 6,516,227, U.S. Patent Publication No.2003/0139781, and U.S. patent application Ser. No. 11/138,632, entitled“Low Power Loss Current Digital-to-Analog Converter Used in anImplantable Pulse Generator,” which are expressly incorporated herein byreference. It should be noted that rather than an IPG, the SCM system 10may alternatively utilize an implantable receiver-stimulator (not shown)connected to the modulation leads 12. In this case, the power source,e.g., a battery, for powering the implanted receiver, as well as controlcircuitry to command the receiver-stimulator, will be contained in anexternal controller inductively coupled to the receiver-stimulator viaan electromagnetic link. Data/power signals are transcutaneously coupledfrom a cable-connected transmission coil placed over the implantedreceiver-stimulator. The implanted receiver-stimulator receives thesignal and generates the modulation in accordance with the controlsignals.

As briefly discussed above, the RC 16 and/or CP 18 includes a userinterface configured for receiving input from a user to specify themodulation parameters, including the particular electrodes 26 betweenwhich the electrical pulse trains are to be delivered. The user mayspecify a specific characteristic that cannot be achieved using a singletiming channel, but can be achieved using multiple timing channels tocreate a combined electrical pulse train having this specificcharacteristic, such as those described with respect to FIGS. 6-9.

Although particular embodiments of the present inventions have beenshown and described, it will be understood that it is not intended tolimit the present inventions to the preferred embodiments, and it willbe obvious to those skilled in the art that various changes andmodifications may be made without departing from the spirit and scope ofthe present inventions. Thus, the present inventions are intended tocover alternatives, modifications, and equivalents, which may beincluded within the spirit and scope of the present inventions asdefined by the claims.

1. (canceled)
 2. A neuromodulation system to deliver an electrical pulsetrain with a pattern of pulses, comprising: an electrical terminalconfigured to be coupled to an electrode; modulation output circuitryconfigured to output electrical pulse trains in timing channels to theelectrical terminal; and control circuitry configured to control themodulation output circuitry to combine the electrical pulse trains atthe electrical terminal into the electrical pulse train with the patternof pulses, wherein each of the electrical pulse trains hascharacteristics selected to provide the pattern of pulses.
 3. Theneuromodulation system of claim 2, wherein: each of the electrical pulsetrains has a pulse amplitude; and a sum of the pulse amplitudes providesan amplitude for a pulse in the pattern of pulses.
 4. Theneuromodulation system of claim 2, wherein: each of the electrical pulsetrains has a pulse rate; and a sum of the pulse rates provides an pulserate in the pattern of pulses.
 5. The neuromodulation system of claim 2,wherein the specific characteristic is a pulse rate that exceeds amaximum value, and the combined electrical pulse train has the pulserate that exceeds the maximum value.
 6. The neuromodulation system ofclaim 2, wherein the electrical pulse train with the pattern of pulseshas a varying pulse rate.
 7. The neuromodulation system of claim 2,wherein the control circuitry is configured to control the modulationoutput circuitry to interleave pulses of the electrical pulses trains.8. The neuromodulation system of claim 2, wherein the control circuitryis configured to control the modulation output circuitry to sequentiallyburst the electrical pulse trains to create the combined electricalpulse train.
 9. The neuromodulation system of claim 2, furthercomprising at least one other electrical terminal configured to berespectfully coupled to at least one other electrode, wherein thecontrol circuitry is configured to control the modulation outputcircuitry to combine the electrical pulses trains at more than oneelectrical terminal.
 10. The neuromodulation system of claim 2, furthercomprising a user interface configured to receive an input from a userto define a characteristic of the electrical pulse train with thepattern of pulses.
 11. The neuromodulation system of claim 2, whereinthe modulation output circuitry is configured to output electrical pulsetrains in up to four timing channels to the electrical terminal.
 12. Amethod of providing neuromodulation therapy to a patient, comprising:delivering an electrical pulse train with a pattern of pulses from anelectrode, including generating electrical pulse trains in timingchannels and combining the electrical pulse trains to provide theelectrical pulse train with the pattern of pulses, wherein each of theelectrical pulse trains has characteristics selected to provide theelectrical pulse train with the pattern of pulses.
 13. The method ofclaim 12, wherein each of the electrical pulse trains in timing channelshas a pulse amplitude, and combining the electrical pulse trainsincludes summing pulse amplitudes of the electrical pulse trains. 14.The method of claim 12, wherein each of the electrical pulse trains intiming channels has a pulse rate, and combining the electrical pulsetrains includes summing pulse rates of the electrical pulse trains. 15.The method of claim 12, wherein the electrical pulse train with thepattern of pulses has a varying pulse rate.
 16. The method of claim 12,further comprising delivering the electrical pulse train with thepattern of pulses from at least one other electrode.
 17. The method ofclaim 12, further comprising receiving input from a user defining acharacteristic of the electrical pulse train with the pattern of pulses.18. The method of claim 12, wherein generating electrical pulse trainsincludes generating electrical pulse trains in up to four timingchannels.
 19. The method of claim 12, wherein combining the electricalpulse trains to provide the electrical pulse train with the pattern ofpulses includes interleaving pulses of the electrical pulse trains. 20.The method of claim 12, wherein combining the electrical pulse trains toprovide the electrical pulse train with the pattern of pulses includessequentially bursting the electrical pulse trains to create the combinedelectrical pulse train.
 21. The method of claim 12, further comprisingusing a user interface to receive an input to define a characteristic ofthe electrical pulse train with the pattern of pulses.